Fosinopril sodium

Product NDC: 43547-388
11-digit product format: 435470388
Labeler code: 43547
Product ID: 43547-388_e39b61db-42b8-4ddf-89d1-549c08d49e71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fosinopril sodium
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare LLC
Application: ANDA205670
Marketing category: ANDA
Marketing start: 2017-10-01
Substance: FOSINOPRIL SODIUM
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205670-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29
A205670-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29
A205670-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205670-001	AB
A205670-002	AB
A205670-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205670-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205670-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205670-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Fosinopril sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSINOPRIL SODIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NW2RTH6T2N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857169	Internal RxNorm lookup
857183	Internal RxNorm lookup
857187	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0a66f606-5e6f-473d-8a1e-9ef316adb2e2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
90aa3f6a-97f0-be7e-d25b-b26d56ae287e	Product name	3	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-388-09	Fosinopril sodium	90 in 1 BOTTLE	TABLET	90		3
43547-388-11	Fosinopril sodium	1000 in 1 BOTTLE	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-388-09	EA - Each	43547-388	3ec3e813-bcd3-4f98-9617-286224c9b64f	1	2017-11-06
43547-388-11	EA - Each	43547-388	7d8ffcc7-f51b-4d26-875c-6774715ab297	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-388	FOSINOPRIL SODIUM (FOSINOPIRL SODIUM) TABLET FOSINOPRIL SODIUM TABLET [SOLCO HEALTHCARE LLC]	2	Current NDC, Legacy NDC, 2 package rows	20200120_0a66f606-5e6f-473d-8a1e-9ef316adb2e2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril sodium	FOSINOPIRL SODIUM	Bryant Ranch Prepack	3d521d4d-29f8-40d7-971b-0efb68dfbff2	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670
Fosinopril sodium	FOSINOPRIL SODIUM	A-S Medication Solutions	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670
Fosinopril sodium	FOSINOPRIL SODIUM	Bryant Ranch Prepack	ee78de8e-22f4-4c3b-a721-e9464d704eda	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670
Fosinopril sodium	FOSINOPIRL SODIUM	Solco Healthcare LLC	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	2021-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670 ndc (product): 43547-388

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857187	fosinopril sodium 40 MG Oral Tablet	PSN	ee78de8e-22f4-4c3b-a721-e9464d704eda	100
857187	fosinopril sodium 40 MG Oral Tablet	SCD	ee78de8e-22f4-4c3b-a721-e9464d704eda	100
857187	FNP Sodium 40 MG Oral Tablet	SY	ee78de8e-22f4-4c3b-a721-e9464d704eda	100
857187	fosinopril sodium 40 MG Oral Tablet	PSN	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	7
857187	fosinopril sodium 40 MG Oral Tablet	SCD	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	7
857187	FNP Sodium 40 MG Oral Tablet	SY	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	7
857169	fosinopril sodium 10 MG Oral Tablet	PSN	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857183	fosinopril sodium 20 MG Oral Tablet	PSN	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857187	fosinopril sodium 40 MG Oral Tablet	PSN	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857169	fosinopril sodium 10 MG Oral Tablet	SCD	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857183	fosinopril sodium 20 MG Oral Tablet	SCD	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857187	fosinopril sodium 40 MG Oral Tablet	SCD	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857169	FNP Sodium 10 MG Oral Tablet	SY	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857183	FNP Sodium 20 MG Oral Tablet	SY	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3
857187	FNP Sodium 40 MG Oral Tablet	SY	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-388-09	43547038809	90 TABLET in 1 BOTTLE (43547-388-09)	90 tablet	2017-10-01	0000-00-00	No	No	Current
43547-388-11	43547038811	1000 TABLET in 1 BOTTLE (43547-388-11)	1000 tablet	2017-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosinopril Sodium Tablets, USP, for oral use Rx only	A-S Medication Solutions	2023-09-25	HUMAN PRESCRIPTION DRUG LABEL	7
Fosinopril Sodium Tablets, USP, for oral use Rx only	Bryant Ranch Prepack	2023-05-11	HUMAN PRESCRIPTION DRUG LABEL	100
Fosinopril Sodium Tablets, USP Rx only	AvPAK	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Fosinopril Sodium Tablets, USP, for oral use Rx only	Solco Healthcare LLC	2021-10-25	HUMAN PRESCRIPTION DRUG LABEL	3
Fosinopril Sodium Tablets, USP, for oral use Rx only	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-03-31	HUMAN PRESCRIPTION DRUG LABEL	1